stay.safe® 050-95001Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00840861100767), received between Jun 15, 2017 and Jul 22, 2025 — classified as 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 23, 2024Class IOpen, Classified

   The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

   Z-1323-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A SPONTANEOUS DISCONNECTION OF THE STAY SAFE/SAFE LOCK CATHETER EXT. SET FROM THE PERITONEAL DIALYSIS (PD) CATHETER WHILE THIS PD PATIENT WAS IN BED FOR PD TREATMENT. DURING FOLLOW-UP IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE CLINIC CHARGE NURSE (CN). THE PATIENT REPORTED WAKING UP IN THE MORNING OF (B)(6) 2025 TO USE THE RESTROOM. THE PATIENT NOTICED EVERYTHING WAS WET. THE STAY SAFE/SAFE LOCK CATHETER EXT. SET HAD DISCONNECTED AND PULLED ALL THE TUBING FROM THE PD CATHETER. THE PATIENT WAS SEEN IN THE PD CLINIC LATER THAT DAY. WHEN THE PATIENT ARRIVED AT THE CLINIC, NO SYMPTOMS OF PERITONITIS WERE REPORTED. THE PATIENT DID REPORT DIARRHEA BUT ATTRIBUTED THAT TO A COMMON ISSUE WHEN HER DIABETES IS NOT UNDER CONTROL. THE PATIENT HAD A PD CULTURE OBTAINED. THE STAY SAFE/SAFE LOCK CATHETER EXT. SET WAS CHANGED. THE PATIENT WAS INITIATED ON PROPHYLACTIC ANTIBIOTICS AT THAT TIME WITH FLUCONAZOLE (ROUTE, DOSE, FREQUENCY, AND DURATION NOT PROVIDED). THE CULTURE RESULTED POSITIVE FOR GRAM-NEGATIVE STAPHYLOCOCCUS (NO SPECIES PROVIDED) AND LEUCONOSTOC MESENTEROIDES. THE PATIE

  Patient problems: Diarrhea; Peritonitis

  MAUDE report 22568417 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A STAY SAFE/LUER LOCK CATHETER EXTENSION SET FOR RENAL REPLACEMENT THERAPY (RRT) WILL BE GETTING HER PD CATHETER (NOT A FRESENIUS PRODUCT) REMOVED DUE TO CONTRACTING PERITONITIS. FOLLOW-UP DOCUMENTATION FROM THE PATIENTS¿ PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC AFTER HER PD CATHETER (NOT A FRESENIUS PRODUCT) DISCONNECTED FROM THE TRANSFER SET (NO VISIBLE DAMAGE NOTED). A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 122 MM3, POLYMORPHS = 73%) WERE COLLECTED, AND THE PATIENT WAS SENT HOME. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR ENTEROCOCCUS FAECALIS, STENOTROPHOMONAS MALTOPHILIA, AND COMAMONAS TESTOSTERONI ON (B)(6) 2025, AND THE PATIENT WAS TREATED WITH A SINGLE INTRAPERITONEAL (IP) DOSE OF GENTAMYCIN 80 MG. THE PDRN ATTRIBUTED CAUSALITY TO THE PATIENT SWIMMING IN A POOL ON MULTIPLE OCCASIONS WHICH COULD HAVE CONTRIBUTED TO THE DISCONNECTION OF THE TRANSFER SET (SAMPLE UNAVAILABLE) FROM THE PD CATHETER. AS A RESULT, THE PATIENT¿S PD CATHETER WAS SCHEDULED T

  Patient problems: Peritonitis

  MAUDE report 22322979 ↗
• MalfunctionMay 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE CATHETER DURING DRAIN 2 OF 4 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING A DRAINING SLOWLY ALARM DURING DRAIN 2 OF 4 OF TREATMENT AND TREATMENT WAS CANCELLED. THE PATIENT STATED A LOT OF FLUID CAME OUT. THE PATIENT STATED HE WAS ABLE TO REPAIR THE LEAK BUT IS NOW RECEIVING DRAINING SLOWLY ALARMS, WHICH HE BELIEVES IS DUE TO ALL THE FLUID COMING OUT FROM THE CATHETER. THE CAUSE OF THE LEAK IS UNKNOWN. UPON FOLLOW UP, THE PDRN CONFIRMED THE REPORTED FLUID LEAK EVENT OCCURRED ON THE PATIENT'S PD CATHETER. THE PDRN CONFIRMED THAT THE PATIENT CAME INTO THE CLINIC THE NEXT DAY TO REPORT THE INCIDENT AND WAS TESTED FOR PERITONITIS. THE TESTS CAME UP NEGATIVE FOR PERITONITIS, HOWEVER A CRACK WAS FOUND ON THE PD CATHETER (NOT A FRESENIUS PRODUCT). THE PDRN DID NOT HAVE THE CATALOG NUMBER OF THE PD CATHETER BUT MENTIONED THE TRANSFER SET WAS CHANGED OUT TO ADDRESS THE CRACK. THE PDRN STATED THAT THE PATIENT CONFIRMED THERE WERE NO OTHER LEAKS FOUND WITH THE CYCLER OR CYCLER SET USED. THE PDRN STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281539 ↗
• InjuryFeb 13, 2024Crack; Crack

  ON (B)(6) 2024, A NX-STAGE AREA MANAGER REPORTED TO POST MARKET SURVEILLANCE THAT THERE WAS AN ALLEGATION OF A POSSIBLE PRODUCT DEFICIENCY INVOLVING THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION (PRODUCT NUMBER (B)(4)) IN THE HATTIESBURG, MS CLINIC. THE AREA MANAGER PROVIDED THE NURSE CONTACT EMAIL AND ADDITIONAL FOLLOW-UP WAS PERFORMED. ON (B)(6) 2024, THE NURSE CONTACT REPORTED THAT THE HATTIESBURG CLINIC HAD A FEW PATIENTS THAT EXPERIENCED A CRACK IN THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION SET (WHERE THE RED END MEETS THE COPAK) AND AS A RESULT SOME OF THE PATIENT¿S DEVELOPED PERITONITIS. IN AN ADDITIONAL FOLLOW-UP CALL TO THE NURSE CONTACT, IT WAS REPORTED THAT THERE WERE FIVE PERITONEAL DIALYSIS (PD)PATIENTS WHO DEVELOPED PERITONITIS IN ASSOCIATION WITH THE CRACKED PD CATHETER EXTENSION SETS. THE FIVE PERITONITIS EVENTS OCCURRED OVER TIME WITH THE FIRST EVENT OCCURRING ON (B)(6) 2023 AND THE LAST REPORTED EVENT ON (B)(6) 2024. PER CLINIC PROTOCOL, DURING A PD CLINIC VISIT EACH PATIENT HAS THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION CHANGED. PER THE NURSE, EACH CRACK IN THE EXTENSION SET WAS DISCOVERED WHEN THE PATIENT CAME INTO THE PD CLINIC. PER T

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18697313 ↗
• InjuryFeb 13, 2024Crack; Crack

  ON (B)(6) 2024, A NX-STAGE AREA MANAGER REPORTED TO POST MARKET SURVEILLANCE THAT THERE WAS AN ALLEGATION OF A POSSIBLE PRODUCT DEFICIENCY INVOLVING THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION (PRODUCT NUMBER 050-95001) IN THE (B)(6) CLINIC. THE AREA MANAGER PROVIDED THE NURSE CONTACT EMAIL AND ADDITIONAL FOLLOW-UP WAS PERFORMED. ON (B)(6) 2024, THE NURSE CONTACT REPORTED THAT THE (B)(6) CLINIC HAD A FEW PATIENTS THAT EXPERIENCED A CRACK IN THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION SET (WHERE THE RED END MEETS THE COPAK) AND AS A RESULT SOME OF THE PATIENT¿S DEVELOPED PERITONITIS. IN AN ADDITIONAL FOLLOW-UP CALL TO THE NURSE CONTACT, IT WAS REPORTED THAT THERE WERE FIVE PERITONEAL DIALYSIS (PD)PATIENTS WHO DEVELOPED PERITONITIS IN ASSOCIATION WITH THE CRACKED PD CATHETER EXTENSION SETS. THE FIVE PERITONITIS EVENTS OCCURRED OVER TIME WITH THE FIRST EVENT OCCURRING ON 2/FEB/2023 AND THE LAST REPORTED EVENT ON 4/JAN/2024. PER CLINIC PROTOCOL, DURING A PD CLINIC VISIT EACH PATIENT HAS THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION CHANGED. PER THE NURSE, EACH CRACK IN THE EXTENSION SET WAS DISCOVERED WHEN THE PATIENT CAME INTO THE PD CLINIC. PER THE NURSE, ALL

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18697311 ↗
• InjuryFeb 12, 2024Crack; Crack

  ON (B)(6) 2024, A NX-STAGE AREA MANAGER REPORTED TO POST MARKET SURVEILLANCE THAT THERE WAS AN ALLEGATION OF A POSSIBLE PRODUCT DEFICIENCY INVOLVING THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION (PRODUCT NUMBER 050-95001) IN THE (B)(6) CLINIC. THE AREA MANAGER PROVIDED THE NURSE CONTACT EMAIL AND ADDITIONAL FOLLOW-UP WAS PERFORMED. ON (B)(6) 2024, THE NURSE CONTACT REPORTED THAT THE (B)(6) CLINIC HAD A FEW PATIENTS THAT EXPERIENCED A CRACK IN THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION SET (WHERE THE RED END MEETS THE COPAK) AND AS A RESULT SOME OF THE PATIENT¿S DEVELOPED PERITONITIS. IN AN ADDITIONAL FOLLOW-UP CALL TO THE NURSE CONTACT, IT WAS REPORTED THAT THERE WERE FIVE PERITONEAL DIALYSIS (PD)PATIENTS WHO DEVELOPED PERITONITIS IN ASSOCIATION WITH THE CRACKED PD CATHETER EXTENSION SETS. THE FIVE PERITONITIS EVENTS OCCURRED OVER TIME WITH THE FIRST EVENT OCCURRING ON (B)(6) 2023 AND THE LAST REPORTED EVENT ON (B)(6) 2024. PER CLINIC PROTOCOL, DURING A PD CLINIC VISIT EACH PATIENT HAS THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION CHANGED. PER THE NURSE, EACH CRACK IN THE EXTENSION SET WAS DISCOVERED WHEN THE PATIENT CAME INTO THE PD CLINIC. PER THE NURSE, A

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18692253 ↗
• InjuryFeb 12, 2024Crack; Crack

  ON (B)(6) 2024, A NX-STAGE AREA MANAGER REPORTED TO POST MARKET SURVEILLANCE THAT THERE WAS AN ALLEGATION OF A POSSIBLE PRODUCT DEFICIENCY INVOLVING THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION (PRODUCT NUMBER 050-95001) IN THE HATTIESBURG, MS CLINIC. THE AREA MANAGER PROVIDED THE NURSE CONTACT EMAIL AND ADDITIONAL FOLLOW-UP WAS PERFORMED. ON (B)(6) 2024, THE NURSE CONTACT REPORTED THAT THE HATTIESBURG CLINIC HAD A FEW PATIENTS THAT EXPERIENCED A CRACK IN THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION SET (WHERE THE RED END MEETS THE COPAK) AND AS A RESULT SOME OF THE PATIENT¿S DEVELOPED PERITONITIS. IN AN ADDITIONAL FOLLOW-UP CALL TO THE NURSE CONTACT, IT WAS REPORTED THAT THERE WERE FIVE PERITONEAL DIALYSIS (PD)PATIENTS WHO DEVELOPED PERITONITIS IN ASSOCIATION WITH THE CRACKED PD CATHETER EXTENSION SETS. THE FIVE PERITONITIS EVENTS OCCURRED OVER TIME WITH THE FIRST EVENT OCCURRING ON (B)(6) 2023 AND THE LAST REPORTED EVENT ON (B)(6) 2024. PER CLINIC PROTOCOL, DURING A PD CLINIC VISIT EACH PATIENT HAS THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION CHANGED. PER THE NURSE, EACH CRACK IN THE EXTENSION SET WAS DISCOVERED WHEN THE PATIENT CAME INTO THE PD CLINIC. PE

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18692011 ↗
• InjuryFeb 12, 2024Crack; Crack

  ON (B)(6) 2024, A NX-STAGE AREA MANAGER REPORTED TO POST MARKET SURVEILLANCE THAT THERE WAS AN ALLEGATION OF A POSSIBLE PRODUCT DEFICIENCY INVOLVING THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION (PRODUCT NUMBER 050-95001) IN THE (B)(6) CLINIC. THE AREA MANAGER PROVIDED THE NURSE CONTACT EMAIL AND ADDITIONAL FOLLOW-UP WAS PERFORMED. ON (B)(6) 2024, THE NURSE CONTACT REPORTED THAT THE (B)(6) CLINIC HAD A FEW PATIENTS THAT EXPERIENCED A CRACK IN THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION SET (WHERE THE RED END MEETS THE COPAK) AND AS A RESULT SOME OF THE PATIENT¿S DEVELOPED PERITONITIS. IN AN ADDITIONAL FOLLOW-UP CALL TO THE NURSE CONTACT, IT WAS REPORTED THAT THERE WERE FIVE PERITONEAL DIALYSIS (PD)PATIENTS WHO DEVELOPED PERITONITIS IN ASSOCIATION WITH THE CRACKED PD CATHETER EXTENSION SETS. THE FIVE PERITONITIS EVENTS OCCURRED OVER TIME WITH THE FIRST EVENT OCCURRING ON (B)(6) 2023 AND THE LAST REPORTED EVENT ON (B)(6) 2024. PER CLINIC PROTOCOL, DURING A PD CLINIC VISIT EACH PATIENT HAS THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION CHANGED. PER THE NURSE, EACH CRACK IN THE EXTENSION SET WAS DISCOVERED WHEN THE PATIENT CAME INTO THE PD CLINIC. PER THE NURSE, A

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18686734 ↗
• InjuryFeb 12, 2024Crack; Crack

  ON (B)(6) 2024, A NX-STAGE AREA MANAGER REPORTED TO POST MARKET SURVEILLANCE THAT THERE WAS AN ALLEGATION OF A POSSIBLE PRODUCT DEFICIENCY INVOLVING THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION (PRODUCT NUMBER 050-95001) IN THE HATTIESBURG, MS CLINIC. THE AREA MANAGER PROVIDED THE NURSE CONTACT EMAIL AND ADDITIONAL FOLLOW-UP WAS PERFORMED. ON (B)(6) 2024, THE NURSE CONTACT REPORTED THAT THE HATTIESBURG CLINIC HAD A FEW PATIENTS THAT EXPERIENCED A CRACK IN THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION SET (WHERE THE RED END MEETS THE COPAK) AND AS A RESULT SOME OF THE PATIENT¿S DEVELOPED PERITONITIS. IN AN ADDITIONAL FOLLOW-UP CALL TO THE NURSE CONTACT, IT WAS REPORTED THAT THERE WERE FIVE PERITONEAL DIALYSIS (PD)PATIENTS WHO DEVELOPED PERITONITIS IN ASSOCIATION WITH THE CRACKED PD CATHETER EXTENSION SETS. THE FIVE PERITONITIS EVENTS OCCURRED OVER TIME WITH THE FIRST EVENT OCCURRING ON (B)(6) 2023 AND THE LAST REPORTED EVENT ON (B)(6) 2024. PER CLINIC PROTOCOL, DURING A PD CLINIC VISIT EACH PATIENT HAS THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION CHANGED. PER THE NURSE, EACH CRACK IN THE EXTENSION SET WAS DISCOVERED WHEN THE PATIENT CAME INTO THE PD CLINIC. PE

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18686731 ↗
• InjuryFeb 12, 2024Crack; Crack

  ON 24/JAN/2024, A NX-STAGE AREA MANAGER REPORTED TO POST MARKET SURVEILLANCE THAT THERE WAS AN ALLEGATION OF A POSSIBLE PRODUCT DEFICIENCY INVOLVING THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION (PRODUCT NUMBER 050-95001) IN THE HATTIESBURG, MS CLINIC. THE AREA MANAGER PROVIDED THE NURSE CONTACT EMAIL AND ADDITIONAL FOLLOW-UP WAS PERFORMED. ON 25/JAN/2024, THE NURSE CONTACT REPORTED THAT THE HATTIESBURG CLINIC HAD A FEW PATIENTS THAT EXPERIENCED A CRACK IN THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION SET (WHERE THE RED END MEETS THE COPAK) AND AS A RESULT SOME OF THE PATIENT¿S DEVELOPED PERITONITIS. IN AN ADDITIONAL FOLLOW-UP CALL TO THE NURSE CONTACT, IT WAS REPORTED THAT THERE WERE FIVE PERITONEAL DIALYSIS (PD)PATIENTS WHO DEVELOPED PERITONITIS IN ASSOCIATION WITH THE CRACKED PD CATHETER EXTENSION SETS. THE FIVE PERITONITIS EVENTS OCCURRED OVER TIME WITH THE FIRST EVENT OCCURRING ON 2/FEB/2023 AND THE LAST REPORTED EVENT ON 4/JAN/2024. PER CLINIC PROTOCOL, DURING A PD CLINIC VISIT EACH PATIENT HAS THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION CHANGED. PER THE NURSE, EACH CRACK IN THE EXTENSION SET WAS DISCOVERED WHEN THE PATIENT CAME INTO THE PD CLINIC. PER

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18686104 ↗
• InjuryFeb 12, 2024Crack; Crack

  ON 24/JAN/2024, A NX-STAGE AREA MANAGER REPORTED TO POST MARKET SURVEILLANCE THAT THERE WAS AN ALLEGATION OF A POSSIBLE PRODUCT DEFICIENCY INVOLVING THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION (PRODUCT NUMBER 050-95001) IN THE HATTIESBURG, MS CLINIC. THE AREA MANAGER PROVIDED THE NURSE CONTACT EMAIL AND ADDITIONAL FOLLOW-UP WAS PERFORMED. ON (B)(6) 2024, THE NURSE CONTACT REPORTED THAT THE HATTIESBURG CLINIC HAD A FEW PATIENTS THAT EXPERIENCED A CRACK IN THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION SET (WHERE THE RED END MEETS THE COPAK) AND AS A RESULT SOME OF THE PATIENT¿S DEVELOPED PERITONITIS. IN AN ADDITIONAL FOLLOW-UP CALL TO THE NURSE CONTACT, IT WAS REPORTED THAT THERE WERE FIVE PERITONEAL DIALYSIS (PD)PATIENTS WHO DEVELOPED PERITONITIS IN ASSOCIATION WITH THE CRACKED PD CATHETER EXTENSION SETS. THE FIVE PERITONITIS EVENTS OCCURRED OVER TIME WITH THE FIRST EVENT OCCURRING ON (B)(6) 2023 AND THE LAST REPORTED EVENT ON (B)(6) 2024. PER CLINIC PROTOCOL, DURING A PD CLINIC VISIT EACH PATIENT HAS THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION CHANGED. PER THE NURSE, EACH CRACK IN THE EXTENSION SET WAS DISCOVERED WHEN THE PATIENT CAME INTO THE PD CLINIC. PE

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18685919 ↗
• InjuryFeb 12, 2024Crack; Crack

  ON (B)(6) 2024, A NX-STAGE AREA MANAGER REPORTED TO POST MARKET SURVEILLANCE THAT THERE WAS AN ALLEGATION OF A POSSIBLE PRODUCT DEFICIENCY INVOLVING THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION (PRODUCT NUMBER 050-95001) IN THE (B)(6). THE AREA MANAGER PROVIDED THE NURSE CONTACT EMAIL AND ADDITIONAL FOLLOW-UP WAS PERFORMED. ON (B)(6) 2024, THE NURSE CONTACT REPORTED THAT THE (B)(6) HAD A FEW PATIENTS THAT EXPERIENCED A CRACK IN THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION SET (WHERE THE RED END MEETS THE COPAK) AND AS A RESULT SOME OF THE PATIENT¿S DEVELOPED PERITONITIS. IN AN ADDITIONAL FOLLOW-UP CALL TO THE NURSE CONTACT, IT WAS REPORTED THAT THERE WERE FIVE PERITONEAL DIALYSIS (PD)PATIENTS WHO DEVELOPED PERITONITIS IN ASSOCIATION WITH THE CRACKED PD CATHETER EXTENSION SETS. THE FIVE PERITONITIS EVENTS OCCURRED OVER TIME WITH THE FIRST EVENT OCCURRING ON 2/FEB/2023 AND THE LAST REPORTED EVENT ON 4/JAN/2024. PER CLINIC PROTOCOL, DURING A PD CLINIC VISIT EACH PATIENT HAS THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION CHANGED. PER THE NURSE, EACH CRACK IN THE EXTENSION SET WAS DISCOVERED WHEN THE PATIENT CAME INTO THE PD CLINIC. PER THE NURSE, ALL THE ACTUAL SA

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18685816 ↗
• InjuryFeb 12, 2024Crack; Crack

  ON 24/JAN/2024, A NX-STAGE AREA MANAGER REPORTED TO POST MARKET SURVEILLANCE THAT THERE WAS AN ALLEGATION OF A POSSIBLE PRODUCT DEFICIENCY INVOLVING THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION (PRODUCT NUMBER: 050-95001) IN THE (B)(6) CLINIC. THE AREA MANAGER PROVIDED THE NURSE CONTACT EMAIL AND ADDITIONAL FOLLOW-UP WAS PERFORMED. ON (B)(6) 2024, THE NURSE CONTACT REPORTED THAT THE (B)(6) CLINIC HAD A FEW PATIENTS THAT EXPERIENCED A CRACK IN THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION SET (WHERE THE RED END MEETS THE COPAK) AND AS A RESULT SOME OF THE PATIENT¿S DEVELOPED PERITONITIS. IN AN ADDITIONAL FOLLOW-UP CALL TO THE NURSE CONTACT, IT WAS REPORTED THAT THERE WERE FIVE PERITONEAL DIALYSIS (PD)PATIENTS WHO DEVELOPED PERITONITIS IN ASSOCIATION WITH THE CRACKED PD CATHETER EXTENSION SETS. THE FIVE PERITONITIS EVENTS OCCURRED OVER TIME WITH THE FIRST EVENT OCCURRING ON 2/FEB/2023 AND THE LAST REPORTED EVENT ON 4/JAN/2024. PER CLINIC PROTOCOL, DURING A PD CLINIC VISIT EACH PATIENT HAS THE FRESENIUS STAY SAFE/SAFE LOCK CATHETER EXTENSION CHANGED. PER THE NURSE, EACH CRACK IN THE EXTENSION SET WAS DISCOVERED WHEN THE PATIENT CAME INTO THE PD CLINIC. PER THE NURSE, AL

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18685768 ↗
• InjuryNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED A FLUID LEAK DURING PD TREATMENT. THERE WAS AN AIR DETECTED IN CASSETTE WARNING DURING DRAIN 3 OF 5. THE PATIENT FOUND A FLUID LEAK IN THE PATIENT LINE AND ATTEMPTED TO TAPE THE TUBE AND PROCEEDED WITH TREATMENT. PATIENT THEN GOT A WATCHDOG TIMER ERROR. TECH SERVICES ASSISTED PATIENT IN A RE-SETUP AND RE-STARTED PATIENT AT FILL 4 OF 6. IN A FOLLOW UP WITH PD NURSE AT THE FACILITY IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL WITH PERITONITIS. UPON FOLLOW UP WITH THE PATIENT¿S PDRN, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED ON (B)(6) 2022 FOR VENTRICULAR TACHYCARDIA DUE TO PREEXISTING CARDIAC DISEASE. THE PATIENT ALSO PRESENTED WITH A FEVER, LETHARGY, ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID DETERMINED TO BE UNRELATED TO THE PATIENT¿S VENTRICULAR TACHYCARDIA. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT WERE OBTAINED IN THE HOSPITAL (EXACT DATE UNKNOWN); HOWEVER, LABORATORY RESULTS WERE NOT REPORTED TO THE OUTPATIENT CLINIC. THE OUTPATIENT CLINIC¿S PHYSICIAN WAS ADVISED THE INFECTIOUS PATHOGEN THAT CAUSED THE PATIENT¿S PERITONITIS INVOLVED A BACTERIUM FOUND ONLY IN CATS. THE GENUS AND SPECIES

  Patient problems: Abdominal Pain; Fever; Lethargy; Peritonitis

  MAUDE report 15844314 ↗
• InjuryNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED A FLUID LEAK DURING PD TREATMENT. THERE WAS AN AIR DETECTED IN CASSETTE WARNING DURING DRAIN 3 OF 5. THE PATIENT FOUND A FLUID LEAK IN THE PATIENT LINE AND ATTEMPTED TO TAPE THE TUBE AND PROCEEDED WITH TREATMENT. PATIENT THEN GOT A WATCHDOG TIMER ERROR. TECH SERVICES ASSISTED PATIENT IN A RE-SETUP AND RE-STARTED PATIENT AT FILL 4 OF 6. IN A FOLLOW UP WITH PD NURSE AT THE FACILITY IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL WITH PERITONITIS. UPON FOLLOW UP WITH THE PATIENT¿S PDRN, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED ON (B)(6) 2022 FOR VENTRICULAR TACHYCARDIA DUE TO PREEXISTING CARDIAC DISEASE. THE PATIENT ALSO PRESENTED WITH A FEVER, LETHARGY, ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID DETERMINED TO BE UNRELATED TO THE PATIENT¿S VENTRICULAR TACHYCARDIA. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT WERE OBTAINED IN THE HOSPITAL (EXACT DATE UNKNOWN); HOWEVER, LABORATORY RESULTS WERE NOT REPORTED TO THE OUTPATIENT CLINIC. THE OUTPATIENT CLINIC¿S PHYSICIAN WAS ADVISED THE INFECTIOUS PATHOGEN THAT CAUSED THE PATIENT¿S PERITONITIS INVOLVED A BACTERIUM FOUND ONLY IN CATS. THE GENUS AND SPECIES

  Patient problems: Abdominal Pain; Fever; Lethargy; Peritonitis

  MAUDE report 15844309 ↗
• InjurySep 15, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY A REGISTERED NURSE (RN) THAT THIS PATIENT ON PERITONEAL DIALYSIS (PD) THERAPY DEVELOPED PERITONITIS FROM A TEAR IN THE FRESENIUS STAY SAFE CATHETER EXTENSION SET. IN A FOLLOW-UP CALL WITH THE PATIENT¿S PD NURSE, IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT NOTIFIED THE OUTPATIENT PD CLINIC THAT HE EXPERIENCED A FLUID LEAK FROM THE STAY SAFE CATHETER EXTENSION SET DUE TO A VISIBLE TEAR. LATER THE SAME DAY, THE PATIENT WAS SEEN IN THE PD CLINIC AND HAD A PD CULTURE OBTAINED. PER THE NURSE, THE PATIENT¿S PD CULTURE GENERATED GROWTH OF THE BACTERIA ENTEROCOCCUS SPECIES. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH DAILY CEFTAZIDIME 2 GRAMS INTRA-PERITONEAL (IP) ON AN OUTPATIENT BASIS. THE NURSE STATED IT IS UNKNOWN WHAT CAUSED THE TEAR IN THE STAY SAFE CATHETER EXTENSION SET. IT WAS REPORTED THE PRODUCT WAS DISCARDED AND THEREFORE WAS NOT AVAILABLE TO RETURN TO MANUFACTURER FOR FURTHER PRODUCT ANALYSIS. THE NURSE ATTRIBUTED THE PATIENT¿S PERITONITIS TO A BREACH IN STERILE PD PATHWAY DUE TO THE REPORTED FLUID LEAK. AT THE TIME FOLLOW-UP WAS COMPLETED, IT WAS INDICATED THE PATIENT IS RECOVERING FROM THE PERITONITIS EVENT. FURTHERMORE, THE NURSE STATED THE PA

  Patient problems: Peritonitis

  MAUDE report 15432215 ↗
• InjurySep 15, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY A REGISTERED NURSE (RN) THAT THIS PATIENT ON PERITONEAL DIALYSIS (PD) THERAPY DEVELOPED PERITONITIS FROM A TEAR IN THE FRESENIUS STAY SAFE CATHETER EXTENSION SET. IN A FOLLOW-UP CALL WITH THE PATIENT¿S PD NURSE, IT WAS REPORTED THAT ON 24/AUG/2022 THE PATIENT NOTIFIED THE OUTPATIENT PD CLINIC THAT HE EXPERIENCED A FLUID LEAK FROM THE STAY SAFE CATHETER EXTENSION SET DUE TO A VISIBLE TEAR. LATER THE SAME DAY, THE PATIENT WAS SEEN IN THE PD CLINIC AND HAD A PD CULTURE OBTAINED. PER THE NURSE, THE PATIENT¿S PD CULTURE GENERATED GROWTH OF THE BACTERIA ENTEROCOCCUS SPECIES. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH DAILY CEFTAZIDIME 2 GRAMS INTRA-PERITONEAL (IP) ON AN OUTPATIENT BASIS. THE NURSE STATED IT IS UNKNOWN WHAT CAUSED THE TEAR IN THE STAY SAFE CATHETER EXTENSION SET. IT WAS REPORTED THE PRODUCT WAS DISCARDED AND THEREFORE WAS NOT AVAILABLE TO RETURN TO MANUFACTURER FOR FURTHER PRODUCT ANALYSIS. THE NURSE ATTRIBUTED THE PATIENT¿S PERITONITIS TO A BREACH IN STERILE PD PATHWAY DUE TO THE REPORTED FLUID LEAK. AT THE TIME FOLLOW-UP WAS COMPLETED, IT WAS INDICATED THE PATIENT IS RECOVERING FROM THE PERITONITIS EVENT. FURTHERMORE, THE NURSE STATED THE PA

  Patient problems: Peritonitis

  MAUDE report 15432195 ↗
• MalfunctionMay 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT HAD A FLUID LEAK BETWEEN THEIR STAY SAFE CATHETER EXTENSION SET AND THEIR PD CATHETER DURING TRAINING. UPON FOLLOW-UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THAT THE PATIENT PRESCRIBED PROPHYLACTIC ANTIBIOTICS (VANCOMYCIN, 2 G, SINGLE DOSE, IP AND GENTAMICIN, 2 G, IP, SINGLE DOSE). THE PDRN CONFIRMED THAT DESPITE THE PROPHYLACTIC ANTIBIOTICS, THERE WERE NO SYMPTOMS, ADVERSE EVENTS, OR INJURIES REQUIRING MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE EXTENSION SET IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8605853 ↗
• InjuryJun 19, 2017Disconnection; Disconnection

  DOCUMENTS IN THE COMPLAINT FILE AND MEDICAL RECORDS WERE REVIEWED. ON (B)(6) 2017 END STAGE RENAL DISEASE (ESRD) PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS (CCPD) THERAPY REPORTED ¿HER CATHETER PIECE HAD FALLEN OUT WHILE CLEANING IT¿ AFTER DISCONNECTING FROM THE CYCLER MACHINE DURING NIGHTLY CCPD TREATMENT. ON (B)(6) 2017, DURING A FOLLOW UP CALL WITH THE PD PATIENT¿S NURSE, THE NURSE STATED A CULTURE OF THE PATIENT¿S PD FLUID WAS PERFORMED AND RESULTS INCLUDED A ¿HIGHLY ELEVATED WHITE BLOOD CELL (WBC) COUNT,¿ AND WAS THEREFORE SUBSEQUENTLY DIAGNOSED WITH PERITONITIS (UNKNOWN SIGNS AND SYMPTOMS). ADDITIONALLY, THE PD NURSE STATED THAT THE PATIENT DID NOT REQUIRE SUBSEQUENT HOSPITALIZATION AND WAS STARTED ON ANTIBIOTIC THERAPY OUTPATIENT FOR 14 DAYS WITH VANCOMYCIN AND TOBRAMYCIN (UNKNOWN DATE, STRENGTH, ROUTE AND FREQUENCY). THE PD NURSE AFFIRMED THE PATIENT COMPLETEED PD THERAPY WITH ASEPTIC TECHNIQUE AND THERE WERE NO REPORTS OF FLUID LEAKS DURING THE CCPD TREATMENT PRIOR TO THE EVENT OF PERITONITIS. FURTHERMORE, THE PD NURSE REPORTED THAT THE PATIENT¿S SIGNS AND SYMPTOMS (UNKNOWN) OF PERITONITIS HAD SINCE RESOLVED AND THE PATIENT CONTINUED PD THERA

  Patient problems: Peritonitis

  MAUDE report 6649832 ↗
• MalfunctionJun 15, 2017Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE PERITONEAL DIALYSIS NURSE (PDRN) REPORTED ON (B)(6) 2017 THAT THE SAFE-LOCK END OF THE CATHETER EXTENSION SET OF A PERITONEAL DIALYSIS (PD) PATIENT WAS CRACKED AND THE PORT INSIDE THE SAFE-LOCK END ALSO BROKE OFF AND LODGED ITSELF IN THE PATIENT'S CATHETER. UPON FOLLOW UP WITH THE PDRN ON (B)(6) 2017 IT WAS REPORTED THAT THE PATIENT HAD ENCOUNTERED A FLUID LEAK FROM THE CRACK IN THE CATHETER EXTENSION WHERE IT CONNECTS TO THE CATHETER DURING THE PD TREATMENT. ACCORDING TO THE PDRN, THE PATIENT HAD GONE TO THE CLINIC THE FOLLOWING DAY OF THE EVENT TO HAVE THE CATHETER EXTENSION REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THIS INCIDENT AND THERE WAS NO EFFLUENT CULTURE TEST PERFORMED. ANTIBIOTICS (VANCOMYCIN 2 G AND GENTAMYCIN 40 MG) WERE PRESCRIBED TO THE PATIENT AS PROPHYLACTIC. THE CATHETER EXTENSION SET IN QUESTION WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6642809 ↗